EMA, FDA Say Future Joint API Inspections Likely

EMA has concluded in a recent report that a pilot program investigating the mutual benefits of joint international inspections of API manufacturing facilities has been a success. The collaboration between the EMA, a number of European member states, FDA, and Australia’s Therapeutic Goods Administration (TGA) sought to increase international regulatory information-sharing to enhance global drug quality and safety by building on API GMP standards.

Following the exchange of surveillance lists for API manufacturers in the participating regions of Australia, Europe, and the US, 97 sites were found to be in common. Over the course of the two-year program, 100 inspection reports were subsequently shared and nine joint inspections conducted. The report points to better use of international inspectional resources to enable an increase in valuable inspections performed and improved inspectional coverage.

Despite the overall success and level of commitment by all participants, however, the report claimed that continued collaboration would need innovative tools for real-time information exchange to avoid duplication of efforts. The master list, which was regularly updated with pertinent information, was one such tool developed during the program. In addition to being a rich source of information, it also represented a model on which to design the future Eudra GMP module for sharing of inspection planning.

The FDA has also issued its own press release, which echoed the positive sentiments of the EMA report. “It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone,” said Deborah M. Autor, FDA deputy commissioner for Global Regulatory Operations and Policy. “We are grateful to our European and Australian colleagues for their willingness to partner with us in these pilot programs. The pilots are important stepping stones toward further global regulatory collaboration.”

Looking to the future, the report stated that collaboration would continue in the existing format and be extended to all EMA Member States. In the longer term, the program may be extended to more comparable regulatory authorities and the World Health Organization.